ATRICLIP® LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE® CLIP
Received Nov 21, 2024 · Event occurred Oct 21, 2024
Report 3011706110-2024-00064 · MDR key 20746650
Device
Generic name
Implantable Clip And Clip Applier
Manufacturer
Atricure, Inc.Model number
PRO240Catalog number
A000966
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
72 YR · Male
- Pericardial Effusion
- Pericardial Effusion
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, AND A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE CONDUCTED AS THE LOT NUMBER FOR THE DEVICE WAS NOT REPORTED OR ABLE TO BE ASCERTAINED.
Description of Event or Problem
A PATIENT WAS SCHEDULED FOR CONVERGENT PROCEDURE WITH CONCOMITANT CATHETER-BASED LEFT ATRIAL APPENDAGE OCCLUSION (LAAO), VIA SUB-XIPHOID APPROACH. DUE TO PATIENT'S ANATOMY, BOTH CONVERGENT AND LAAO WERE NOT PERFORMED. LEFT ATRIAL APPENDAGE EXCLUSION (LAAE) VIS LEFT VIDEO-ASSISTED THORACOSCOPY WAS SUCCESSFULLY COMPLETED. PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON POST OPERATIVE DAY 6. ON POST OPERATIVE DAY 10, PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHORTNESS OF BREATH. A DELAYED PERICARDIAL EFFUSION WAS DIAGNOSED AND TREATED WITH PERICARDIOCENTESIS, DURING WHICH 650CC OF FLUID WAS REMOVED. THE PATIENT RECOVERED WITHOUT FURTHER KNOWN COMPLICATIONS. WHILE THERE IS NOT DIRECT CAUSE OR CONTRIBUTION OF THE ATRICURE DEVICE TO THE ADVERSE EVENT, IT IS NOT POSSIBLE TO COMPLETELY RULE OUT POTENTIAL CAUSE OR CONTRIBUTION, THEREFORE THE EVENT IS BEING REPORTED PER 21 CFR PART 803. THERE IS NO REPORTED DEVICE MALFUNCTION, AND THE ADVERSE EVENT WAS THE RESULT OF A PROCEDURAL COMPLICATION.